Auto injector with separate needle injection

ABSTRACT

An auto injector having sequential control of needle insertion and dose injection is disclosed. A syringe with a needle is movably positioned in a housing between a first position in which the needle is accommodated inside the housing and a second position in which the needle protrudes outside the housing. A plunger rod tube has at least one locking member configured to normally lock a plunger rod to the plunger rod tube. A syringe driver applies a force to the syringe to move the syringe together with plunger rod tube, plunger rod and plunger rod driver from the first position to the second position. In the second position, the locking member is unlocked and releases the plunger rod to thereby activate the plunger rod driver to advance the plunger rod in the syringe for delivering of at least one dose of medicament.

TECHNICAL FIELD

The present invention relates to auto injectors, such as medical autoinjectors, and especially to auto injectors which may be capable ofseparate insertion of needle and injection of medicine from a medicinalcartridge or a pre-filled syringe containing medicine. The inventionespecially relates to auto injectors where the needle insertion and themedicine injection may be performed by separate drive means.

BACKGROUND OF THE INVENTION

Auto injectors are well-known in the art, and are often preferred byusers for self administration of medicine, such as for subcutaneousinjection of medicines such as insulin, medicine to treat or alleviatemultiple sclerosis, rheum, lupus, etc. or for emergency injection ofe.g. adrenaline or epinephrine, such as injection in to muscle tissue.

The needles used for injection subcutaneously and for injection intomuscle tissue are typically of different lengths. Typically, needlesused for subcutaneous injections are about 12 mm (“half-inch”) whereasneedles used for injection into muscle tissue may have a length of 20-25mm (“inch”), to ensure that muscle tissue is reached.

The selected needle bore may also affect the degree of patientdiscomfort during injection. Smaller bore diameters, typically providemore patient comfort, whereas larger bore diameters enable more rapiddelivery of the liquid through the needle and with a lower force. Acompromise is therefore needed in selecting needle bore to provideacceptable patient comfort and liquid delivery through the needlecharacteristics.

Allergic reactions tend to become an ever increasing problem and for thetreatment of severe allergic reactions (anaphylaxis) to foods, insectstings or bites, drugs and other allergens, as well as idiopathic orexercise induced anaphylaxis, adrenaline or epinephrine is typicallyused.

Epinephrine works quickly to reverse the symptoms of an anaphylacticreaction and epinephrine injected into the muscle of the front of theupper outer thigh is typically used for the emergency treatment ofanaphylaxis.

Typically, epinephrine auto-injectors are single use injectors forinjecting a pre-measured single dose of epinephrine for the emergencytreatment of anaphylaxis.

WO 2012/045827 discloses an auto injector having an arrangement forcoupling a plunger rod to either a syringe or a stopper arranged in thesyringe. However, it is a disadvantage of the auto injector as disclosedthat a single compression spring is applied for injecting the needle andfor injecting the medicament, in that the resistance of the needlepenetrating the skin may tend to force the syringe backwards in asyringe carrier, whereby the stopper may contact the forward movingplunger rod and expelling the medicament prematurely which may result ina wet injection.

U.S. Pat. No. 7,785,292 discloses an auto injector comprising a housingwherein a single driving mechanism is used to insert the needle and toinject the medicament. The syringe is moved to a forward position beforethe piston is allowed to move forward to inject the medicament. Alocking mechanism engages the drive with the syringe when the syringe isnot in the forward position and engages the syringe with the housingwhen the syringe is in the forward position.

The prior art documents disclose the use of a single drive mechanism,the engagement of which is shifted depending on the position of thesyringe.

SUMMARY OF INVENTION

It is an object of the present invention to provide a reliableseparation of needle insertion and medicament injection to minimize therisk of wet injection, while providing a simple auto injector.

According to a first aspect of the present invention, an auto injectorhaving sequential control of needle insertion and dose injection isprovided. The auto injector may have a housing for accommodation of asyringe with a needle, and the syringe may be movably positioned in thehousing between a first position in which position the needle isaccommodated inside the housing and a second position in which positionthe needle protrudes outside the housing. The housing may furthermoreaccommodate a plunger rod configured to be advanced in the syringe fordelivering at least one dose of medicament, and a plunger rod tube. Theplunger rod tube may have at least one locking member configured tointeract with a plunger rod stop to normally lock the plunger rod to theplunger rod tube. A syringe driver may be configured to apply a force tothe syringe thereby moving the syringe from the first position to thesecond position and the syringe driver may further be configured toadvance the plunger rod tube with the plunger rod to the secondposition. A plunger rod driver may be configured to apply a force to theplunger rod to advance the plunger rod in the syringe for delivering atleast one dose of medicament. The housing may be configured to unlockthe locking member and release the plunger rod from the plunger rod tubewhen the syringe and the plunger rod tube is advanced to the secondposition. Thereby the plunger rod driver may be activated to advance theplunger rod in the syringe for delivering of at least one dose ofmedicament. Thus, the syringe driver and the plunger rod driver may beseparate drivers.

It is advantageous to provide syringe driver and plunger rod driver asseparate driving means in that the risk of wet injection, i.e. liquidmedicament leaking out of the needle during needle insertion, isreduced.

According to another aspect of the present invention, an auto injectorhaving sequential control of needle insertion and dose injection isprovided. The auto injector may have a housing for accommodation of asyringe with a needle, and the syringe may be movably positioned in thehousing between a first position in which position the needle isaccommodated inside the housing and a second position in which positionthe needle protrudes outside the housing. The housing may furthermoreaccommodate a plunger rod configured to be advanced in the syringe fordelivering at least one dose of medicament, and a plunger rod tube. Theplunger rod tube may have at least one locking member configured tointeract with a plunger rod stop to normally lock the plunger rod to theplunger rod tube. A first spring may be configured to apply a force tothe syringe thereby moving the syringe from the first position to thesecond position and the first spring may further be configured toadvance the plunger rod tube with the plunger rod to the secondposition. A second spring may be configured to apply a force to theplunger rod to advance the plunger rod in the syringe for delivering atleast one dose of medicament. The housing may be configured to unlockthe locking member and release the plunger rod from the plunger rod tubewhen the syringe and the plunger rod tube is advanced to the secondposition. Thereby the second spring may be activated to advance theplunger rod in the syringe for delivering of at least one dose ofmedicament.

It is a further advantage of providing a first spring configured toadvance the syringe in the housing and a second spring configured toadvance the plunger rod in the syringe that the spring characteristicsmay be selected according to the purpose. For example, to drive a needleinto the skin a significantly smaller force may typically be needed thanwhen injecting a medicament from a syringe, depending on needle bore.Thus, especially, when the initial force is lower than the force neededfor the injection of the medicament, the design of the springs may becomplex, and difficult obtainable by a single spring.

In a further aspect of the present invention, an auto injector havingsequential control of needle insertion and dose injection is disclosed.A syringe with a needle may be movably positioned in a housing between afirst position in which the needle may be accommodated inside thehousing and a second position in which the needle protrudes outside thehousing. A plunger rod tube may have at least one locking memberconfigured to normally lock a plunger rod to the plunger rod tube. Asyringe driver applies a force to the syringe to move the syringetogether with plunger rod tube, plunger rod and plunger rod driver fromthe first position to the second position. In the second position, thelocking member may be unlocked to release the plunger rod to therebyactivate the plunger rod driver to advance the plunger rod in thesyringe for delivering at least one dose of medicament.

In particular when injecting a medicament into muscle tissue, a longerneedle is typically used compared to needles used for subcutaneousinjections, i.e. the needles used for subcutaneous injections aretypically about 12 mm (“half-inch”), whereas needles used for injectioninto muscle tissue may have a length of 20-25 mm (“inch”), to ensurethat muscle tissue is reached. In consequence of the long needle sizeused for injection into muscle tissue, and still the requirement of aminimum force to facilitate injection of the medicament into the muscletissue, a significant force may have to be stored in the spring. A highpotential energy stored in the spring during the entire shelf life ofthe auto injector also adds to the requirements for the surroundingparts of the auto injector in particular relating to strength and hencecost of manufacturing.

Furthermore, when manufacturing the auto injectors in high volume, thesmall tolerances required when using a single spring for both needleinsertion and medicament injection may be critical. Thus, it is afurther advantage of the present invention that as few parts as possiblemove in relation to each other to thereby obtain a system which is morerobust with respect to the manufacturing process. Also, providing onespring to both insert a needle and inject a medicament requires for thespring to be able to extend over a significant length compared to thespring diameters which may typically be provided for in auto injectors.Furthermore, the design of the spring characteristics, such as forcedistribution, may be much simpler, and therefore reduce the costs of thesprings.

It is seen that the locking member cooperating with the housing or anintermediate member, such as the reload handle, may control the movementof the plunger rod. Thus, the movement of the plunger rod and therebythe injection of medicament is controlled by the housing or theintermediate member.

It is a further advantage of the present invention, that the means forreleasing the syringe to allow insertion of the needle are decoupledfrom the means for releasing the plunger rod for injection ofmedicament. Thus, there is no direct coupling between the end stop forthe needle insertion, which is provided on the syringe lock, and therelease of the plunger rod, which is provided by alignment of plungerrod tube and housing or the intermediate member, such as the reloadhandle. Thereby, an inaccuracy in the needle injection procedure willnot inherently be transferred to the injection of medicament. Thus,while the release of the syringe may be configured to release theplunger rod, the release of the syringe may be mechanically decoupledfrom the plunger rod release.

The locking member may comprise at least one deflectable member and thehousing may be configured to allow for the at least one deflectablemember to enable deflection away from the plunger rod when the syringeand the plunger rod tube has been advanced to the second position.

In one or more embodiments, the plunger rod tube and the syringe may beinterconnected so that the plunger rod tube may not be able to move withrespect to the syringe and vice versa.

The housing may have an opening, such as a window or a widened portion,configured to be aligned with the at least one deflectable member whenthe plunger rod tube is advanced to the second position. By aligning theat least one deflectable member with the opening, the at least onedeflectable member may be configured to deflect through or towards theopening. When the plunger rod tube with the at least one deflectablemember is not in the second position, an inner surface of the housingmay prevent the at least one deflectable locking member from deflecting,such as from deflecting outwards, i.e. deflecting radially with respectto a longitudinal axis of the syringe and/or the plunger rod tube.Hereby, the plunger rod may be locked to the plunger rod tube and theplunger rod driver, such as the second spring, will remain in acompressed state and not be able to force the plunger rod forwards inthe syringe. Only when the plunger rod tube is aligned with the housingopenings will the at least one deflectable member be able to deflect andthereby release or unlock the plunger rod from the plunger rod tube. Asthe plunger rod is released from the plunger rod tube, the plunger roddriver will be activated and force the plunger rod to advance in thesyringe to thereby deliver a dose of medicament.

Thus, upon release of the plunger rod, the plunger rod driver mayadvance the plunger rod within the syringe in that the plunger rod stopis able to pass the deflected locking member. Thereby, the forward endof the plunger rod is advanced in the syringe, and the plunger rod stopmay move forward to an end-of-dose stop in the plunger rod tube.Thereby, the dose to be injected may be determined by the distance fromthe release of the plunger rod, to the end-of-dose stop times a diameterof the syringe.

The plunger rod stop may have an angled surface normally pressingagainst an angular surface of the deflectable locking member. Hereby,the plunger rod forces the deflectable locking member to deflect towardsthe opening when the plunger rod is being pushed forward by the plungerrod driver

In one or more embodiments, the at least one deflectable locking membermay be hinged to the plunger rod tube in a downward position withrespect to the movement of the plunger rod. Hereby, the at least onedeflectable locking member is stronger in that push forces, and not pullforces, are exerted on the at least one deflectable locking member.Another advantage of hinging the deflectable locking member in adownward position is that it is ensured that the deflectable lockingmember may deflect only when the entire length of the deflectablelocking member opposes the full opening. This further implies that theauto injector is more robust in the control of ensuring strictsequential execution of medicament injection only after a fullyestablished needle insertion. In particular, for acute medications withvery fast injection of a drug, i.e. when a large bore needle is used, itis of utmost importance that the sequential control is robust.

As mentioned above, the plunger rod driver may comprise a spring, suchas a compression spring, and in some embodiments, the plunger rod springmay in one end be fixedly connected to the plunger rod tube.

The plunger rod driver may apply the driving force directly onto theplunger rod, such as onto a plunger rod flange, so as to for exampledrive only the plunger rod forwards. It is an advantage of applying thedriving force directly onto the plunger rod in that no complex parts maybe necessary to shift the loading between different parts, andfurthermore, the force may be applied in a controlled manner, withsubstantially no or significantly reduced uncertainty as to how muchforce will actually be applied to the plunger rod, and thereby, how fastthe medicament will be expelled.

The plunger rod driver, such as the second spring, may for example beprovided inside the plunger rod tube, and the syringe driver, such asthe first spring, may be provided outside the plunger rod tube.

The housing may further accommodate a syringe tube for holding thesyringe, and the syringe may have a syringe flange which may then belocked between the syringe tube and the plunger rod tube. Hereby, asyringe assembly comprising the syringe, the syringe tube interconnectedto the plunger rod tube in which the plunger rod and the plunger roddriver are positioned, may be moved as one entity. It is an advantage oflocking the syringe, the syringe tube and the plunger rod tube togetherin that no accidental movement of the parts in relation to each mayinfluence the delivery of the medicament.

In one or more embodiments, the auto injector may be a reloadable autoinjector.

In some embodiments, the auto injector may be configured to deliver morethan one dose of medicament, such as two doses of medicament, such as aplurality of doses of medicament, etc., such as two separate doses ofmedicament, etc. In some embodiments, the delivery of a second or anyfurther doses may require a clear operator input to activate the autoinjector for the further injection.

It is an advantage of the present invention that the auto injector maybe used to deliver one or more doses of medicament, depending on theuser or patient operation of the auto injector. Thus, one or moreindividual doses may be delivered from e.g. a medicinal cartridge orpre-filled syringe containing medicine. It is an advantage of thepresent invention that a clear operator/user or patient input isrequired in order to allow an additional dose to be delivered. Theoperator input may comprise operating a reload mechanism, and the reloadmechanism may comprise activating the auto injector for a furtherinjection.

The plunger rod tube may comprise at least a first and a second lockingmember to enable delivering of a first and/or a second dose, or theplunger rod tube may comprise a plurality of locking members to enabledelivery of a first, second and/or plurality of doses. Each of thefirst, second and/or plurality of locking members may be configured toconsecutively engage with the plunger rod stop. The first, second and/orplurality of locking members may be a first, second and/or plurality ofdeflectable locking members. It is an advantage of the present inventionthat the two windows for release of the plunger rod tube are provided ona same component, i.e. on the reload handle, in that manufacturingtolerances are better controllable.

The housing may comprise a first, a second and/or a plurality ofopenings configured to align with the first, second and/or plurality oflocking members, respectively, when the syringe is the second position.

It is envisaged that the opening(s) may be provided in any intermediateelement, such as in a handle, positioned between the housing and theplunger rod tube. Thus, the deflectable locking members may berestricted by an inner side of such an intermediate element and theopening(s) may be provided in the intermediate element only or in anyintermediate element and the housing, to e.g. allow for a fulldeflection of the locking members.

It is envisaged that the principle as set out allow for any number ofinjections, and the auto injector may comprise one, two and/or aplurality sets of locking members and corresponding openings whereineach locking member and corresponding opening may be provided atindependent positions on the perimeter of the housing and/or anyintermediate element and the plunger rod tuber, respectively.

It is an advantage of providing the openings in one element, such as inthe housing or in an intermediate element, in that substantially onlythe tolerances in the manufacturing of the one element influences thedose delivery control. Thereby, the first and any further dosesdelivered may be aligned with each other, and thereby highlycontrollable.

To deliver more than one dose, the auto injector may be activated morethan once, thus, also the plunger rod driver may be activated one ormore times. The plunger rod driver may be configured to move the plungerrod a first distance upon a first activation of the plunger rod driverand a further distance upon a further activation of the plunger roddriver.

The plunger rod stop may engage the second or further locking memberafter a first or further medicament injection has been performed. Thus,for example, when a first dose has been delivered, the plunger rod stopwill engage the second deflectable locking member, and thereby be readyfor delivering of a second dose as soon as the second deflectablelocking member is aligned with the second opening in the housing.

In one or more embodiments, the second activation of the plunger roddriver may follow a reload of the auto injector, and a repeated movementof the syringe and/or the syringe assembly from the first position tothe second position.

In one or more embodiments of the present invention, a reloadableauto-injector with a housing for accommodation of a syringe assembly maybe provided. The syringe assembly may comprise a syringe with a needle,and the syringe assembly may be movably positioned in the housingbetween a first position in which position the needle is accommodatedinside the housing and a second position in which position the needleprotrudes outside the housing. The syringe assembly may further comprisea plunger rod configured to be advanced in the syringe for delivering atleast one dose of medicament, and a plunger rod driver being configuredto apply a force to the plunger rod to advance the plunger rod in thesyringe for delivering at least one dose of medicament. Furthermore, asyringe driver may be accommodated inside the housing and be configuredto apply a force to the syringe assembly thereby moving the syringe fromthe first position to the second position. The housing may still furthercomprise a reload handle configured to reload the auto injector forinjecting a further dose of medicament, wherein the reload handle may beconnected to the syringe assembly so that user or patient operation ofthe reload handle is configured to retract the syringe assembly to thefirst position and to simultaneously reload the syringe driver tothereby ready the auto injector for delivering a further dose ofmedicament. The syringe assembly may further comprise a syringe stoppermovably positioned in the syringe and sealing syringe content, and aplunger rod configured to engage the syringe stopper.

In one or more embodiments, a reloadable auto-injector with a housingfor accommodation of a syringe assembly comprising a syringe with aneedle may be provided. The syringe assembly may be movably positionedin the housing between a first position in which position the needle isaccommodated inside the housing and a second position in which positionthe needle protrudes outside the housing. The syringe assembly mayfurther comprise a plunger rod driver being configured to apply a forceto a plunger rod to advance the plunger rod in the syringe fordelivering at least one dose of medicament. The housing may furthermoreaccommodate a syringe driver configured to apply a force to the syringeassembly thereby moving the syringe from the first position to thesecond position and the auto injector further comprises a reload handleconfigured to reload the auto injector for injecting a further dose ofmedicament. The reload handle may be connected to the syringe assemblyso that user or patient operation of the reload handle is configured toretract the syringe assembly to the first position and to simultaneouslyreload the syringe driver.

In one or more embodiments, a reloadable auto-injector with a housingfor accommodation of a needle shield and a syringe assembly may beprovided. The syringe assembly may comprise a syringe with a needle anda plunger rod driver being configured to apply a force to a plunger rodto advance the plunger rod in the syringe for delivering at least onedose of medicament. A syringe driver may be configured to apply a forceto the syringe assembly thereby moving the syringe from a first positionto a second position and a reload handle may be configured to reload theauto injector for delivering a further dose of medicament, wherein thereload handle is connected to the syringe assembly and the needle shieldso that user or patient operation of the reload handle is configured toretract the syringe assembly to the first position and to simultaneouslyreload the syringe driver and release the needle shield.

In some embodiments, a method of reloading an auto injector may beprovided, wherein a reloadable auto-injector has a housing foraccommodation of a needle shield and a syringe assembly. The syringeassembly may comprise a syringe with a needle and a plunger rod driverbeing configured to apply a force to a plunger rod to advance theplunger rod in the syringe for delivering at least one dose ofmedicament. A syringe driver may be provided in the housing andconfigured to apply a force to the syringe assembly thereby moving thesyringe from a first position to a second position in which position adose may be delivered. The auto injector may furthermore comprise areload handle configured to reload the auto injector for delivering afurther dose of medicament, wherein the method comprises operating thereload handle to retract the syringe assembly to the first position,reload the syringe driver and release the needle shield to thereby readythe auto injector for delivering a further second dose.

In one or more embodiments, a method of operating a reloadable autoinjector may be provided. The auto injector may comprise a housing foraccommodation of a syringe assembly. The syringe assembly may comprise asyringe with a needle, and the syringe assembly may be movablypositioned in the housing between a first position in which position theneedle is accommodated inside the housing and a second position in whichposition the needle protrudes outside the housing. The syringe assemblymay further comprise a plunger rod driver being configured to apply aforce to a plunger rod to advance the plunger rod in the syringe fordelivering at least one dose of medicament and the housing may furtheraccommodate a syringe driver configured to apply a force to the syringeassembly thereby moving the syringe from the first position to thesecond position, a skin sensor for activation of the auto injector, asyringe lock for locking the syringe assembly in the first position, anda reload handle, wherein the method may comprises the steps ofactivating the skin sensor to rotate the syringe lock and release thesyringe assembly, moving the syringe assembly from the first position tothe second position, releasing the plunger rod driver to deliver a doseof medicament, de-activating the skin sensor to cover the needle andlocking the skin sensor in the de-activated position. The method mayfurther comprise reloading the auto injector by operation of the reloadhandle, wherein the reloading may comprise moving the syringe assemblyfrom the second position to the first position, reloading the syringedriver, locking the syringe assembly in the first position and unlockingthe skin sensor whereby the auto injector is ready for delivering afurther dose of medicament.

In yet other embodiments of the present invention, an auto injector fordelivering at least one dose of medicament may be provided. The autoinjector may have a housing for accommodation of a syringe assemblycomprising a syringe with a needle. The syringe assembly may be movablypositioned in the housing between a first position in which position theneedle is accommodated inside the housing and a second position in whichposition the needle protrudes outside the housing. The auto injector mayfurther comprise a sound generator configured to emit a sound whiledosing.

It is an advantage of the above described auto injectors that themechanism is fully reversible. Thereby, any sharps protection in theform of a skin sensor or the like may be locked in the intermediateposition, i.e. after a first dose is delivered and before the autoinjector is reloaded. Thereby, the patient and/or operator is protectedagainst the needle also in between dose deliveries. It is especially forthe acute treatment of e.g. allergies, advantageous that the needleshield may be locked after the first dose delivery or first doseinjection, as the patient may not need a further treatment and thusdiscard or re-use the auto injector after the first dose delivery. Thus,to safely dispose of the auto injector or the syringe assembly, the skinsensor may advantageously shield the needle after a dose has beendelivered and may furthermore be locked in the forward positionimmediately following a dose delivery.

It is a further advantage of the present invention that the autoinjector has a compact size in that the syringe assembly and the needleshield is retracted upon reload of the device, thereby limiting thelength of the device.

The present invention may provide an auto injector which enables apatient to receive at least two individual injections from one singlesyringe, and the operator or patient may apply similar steps to performthe first, second and any further injection. The patient may have toactivate the auto injector to enable a second or further injection ordelivery of medicament.

Throughout the present disclosure, the auto injector has a front orforward end in the end intended to be pushed against a patient's skin,and a back or backward end towards the other end of the auto injector.The terms “forward” or “downward”, such as forward or downward movementtherefore means towards the forward end, or towards the skin of apatient when the auto injector is positioned in its intended operationalposition for injection. Likewise, backwards or upwards, such asbackwards or upwards movement, means towards the back end of the autoinjector, or away from the skin of a patient when the auto injector ispositioned in its intended operational position for injection.Furthermore, a top end of the auto injector is the back ward end of theauto injector, i.e. the end furthest away from the skin of a patientwhen the auto injector is positioned in its intended operationalposition for injection.

Furthermore, the term “reload” means to ready the auto injector for afurther injection using the same or a different syringe. The reloadingof the auto injector is performed while the syringe is provided in theauto injector. When a driver, such as a spring, is reloaded orre-activated, power is transferred back to the driver. For example, thereloading or re-activation of a spring comprises the reloading oftension on the spring.

In one or more embodiments of the present invention, the reloadable autoinjector may be activated upon unpacking of the device. Especially foremergency injections of medicament, it is advantageous for an operatoror a patient that no further steps are necessary after unpacking thedevice and before activation of the auto injector, such as by pushingthe skin sensor against the skin of a patient.

In one or more embodiments of the present invention, the syringe driverand the plunger rod driver are separate drivers. Thus, the syringedriver may separate from the plunger rod driver, and in someembodiments, the syringe driver may be a resilient device, such as aspring, such as a compression spring. Likewise, the plunger rod drivermay be a resilient device, such as a spring, such as a compressionspring. The syringe driver may be configured to act on the syringeassembly, to drive the syringe assembly from the first position to thesecond position. The syringe driver may be provided in the housing andthe housing may guide or stabilized the syringe driver. The plunger roddriver may be configured to act on the plunger rod and may be providedwithin a plunger rod tube. The plunger rod tube may guide or stabilizethe plunger rod driver.

The auto injector may in some embodiments further comprise a syringelock configured to lock the syringe in the first position, and a skinsensor configured to release the syringe lock upon engagement with theskin of a patient wherein the skin sensor is activated by pressing theskin sensor onto a patient's skin.

The skin sensor may thus be of a cylindrical shape encompassing at leasta part of the syringe assembly, and the skin sensor may be configured toconnect to a skin sensor driver. The skin sensor driver may be aresilient driver, such as a spring. In one or more embodiments, the skinsensor driver is a spring, and the spring may be configured to be in therelaxed position when the skin sensor is positioned in a forwardposition. The skin sensor may for example be activated upon pressing theskin sensor against the skin of a patient. Hereby, the operator maycompress the skin sensor driver, such as the spring, and move the skinsensor backwards away from the skin. The compressed skin sensor driver,such as the spring, may be released as soon as the auto injector isremoved from the skin and the skin sensor will thereby be pushed forwardby the skin sensor driver.

In one or more embodiments, the auto injector may further comprisesafety features, such as a needle protection element, such as a needleshield, to shield the needle and prevent accidental contact with theneedle. In some embodiments, the skin sensor may shield the needle andthus act as a skin sensor configured to release the syringe driver asmentioned above, and further act as needle protection element configuredto shield the needle. It is however envisaged that the needle protectionelement, such as the needle shield, may be an element separate from theskin sensor. In the following, reference may be made to the skin sensor,however, it will be clear for a person skilled in the art thatcorresponding needle protection features could be evenly applied to aneedle protection element separate from the skin sensor.

The needle protection element, such as the skin sensor, may be able tolock in a forward position so as to prevent accidental contact with theneedle. The needle protection element may for example be locked after adose has been injected, and in between multiple injections. The needleprotection element may for example comprise a locking protrusion and thelocking protrusion may be configured to rest on a ledge in the syringelock when a first dose has been delivered locking the needle protectionelement in the forward position and preventing backward motion of theneedle protection element. It is envisaged that the locking of theneedle protection element also may be implemented using any otherlocking mechanism.

The skin sensor may likewise have a locked forward position and anunlocked forward position, and the skin sensor may for example be lockedafter each injection cycle has been completed. It is an advantage oflocking the skin sensor after an injection cycle has been completed inthat the risk of accidental activation of the auto injector for afurther injection is minimized or eliminated. By locking the skin sensorin the locked forward position, it requires a clear operator or patientinput to re-activate the auto injector and prepare it for a furtherinjection cycle. The skin sensor may for example comprise a lockingprotrusion and the locking protrusion may be configured to rest on aledge in the syringe lock when a first dose has been delivered lockingthe skin sensor in the forward position and preventing backward motionof the skin sensor. It is envisaged that the locking of the skin sensormay be implemented using any other locking mechanism.

The reloading handle may be configured to further interact with theneedle protection element and/or the skin sensor to unlock the needleprotection element and/or the skin sensor upon reloading, and in one ormore embodiments, rotation of the reload handle rotates the syringe lockto thereby unlock the needle protection element and/or the skin sensor.In the unlocked position, backward motion of the needle protectionelement and/or the skin sensor may be enabled to thereby ready the autoinjector for a further injection. In one or more embodiments, the needleprotection element and/or the skin sensor is in an unlocked positionupon unpacking of the device and locked after a dose of medicament hasbeen delivered.

It is an advantage of providing the auto injector in a ready-to-usestate right out of the package in that the auto injector may be appliedfor emergency injections of medicament, such as by an anaphylaxisallergy reaction, etc. Thus, for a patient or user, it is of utmostimportance that no considerations or user manual as to the functioningof the auto injector is required, but that the device may inject themedicine directly be pushing the auto injector against the skin.

It is an advantage of providing a locking of the needle protectionelement and/or the skin sensor after the delivery of a dose in that theauto injector in this state may either be discarded or await a furtherinjection of medicament. In both instances it is advantageous that thereis limited or no risk of neither a patient, a user nor any one handlingthe discarded auto injector to contact the needle and/or to accidentallyactivate the auto injector to perform a further dose injection cycle.

Using the reload mechanism to further unlock safety features, such asthe needle protection element, the skin sensor, etc., provides theadvantage of having an auto injector with safety features which is fullyreversible upon reloading of the device. Thereby an auto injector may beprovided with the safety features of a standard auto injector providedin a fully reversible reloadable auto injector.

The syringe may be locked in the first position when the auto injectoris in a position ready for delivering a dose. The syringe may thus belocked in the first position initially, i.e. when the auto injector isunpacked, and after each reload action. The syringe may be locked in thefirst position by a syringe lock. The syringe lock may for example bereleased upon activation of the skin sensor.

The activation of the skin sensor may be configured to cause a backwardmovement of the skin sensor whereby a skin sensor angled surface may beconfigured to engage with a syringe lock angled surface translating thelateral motion of the skin sensor into angular motion of the syringelock. The skin sensor may for example be activated by pressing the skinsensor against the skin of a patient to thereby force the skin sensorbackwards. The syringe lock may have a cylindrical shape and may beconfigured so that the skin sensor, upon moving backward, slides insidethe syringe lock. The skin sensor angled surface may thus be aprotrusion on an outer side of the skin sensor, and the syringe lockangled surface may be a protrusion on a syringe lock inner side, so thatwhen the skin sensor slides inside the syringe lock the skin sensorangled surface and the syringe lock angled surface may engage so thatthe skin sensor angled surface thereby forces the syringe lock torotate.

The syringe lock may further comprise a resting ledge, and the syringeassembly may rest on the resting ledge in the syringe lock to therebylock the syringe assembly in the first position. The angular motion ofthe syringe lock may release the syringe assembly by turning the syringelock and thereby free the syringe assembly from the resting ledge.

In one or more embodiments, the syringe lock may further comprise asyringe lock guide slot, and the syringe assembly may comprise a syringeassembly tab; the syringe assembly tab may be configured to move in thesyringe lock guide slot. The syringe lock guide slot may comprise theresting ledge, and the rotation of the syringe lock may move the tab inthe guide slot from the resting ledge to a released position in whichthe syringe assembly tab may follow a downward guide slot path from thereleased position adjacent the ledge to a syringe lock end stop therebymoving the syringe assembly from the first position to the secondposition. Thus, the syringe assembly may be moved from the firstposition to the second position when the syringe assembly end stoptravels in the syringe lock guide slot from the released position to thesyringe lock end stop.

At least a part of the guide slot may comprise an inclined guide slot sothat the syringe lock may be further rotated upon the movement of thesyringe assembly from the first position to the second position.

The syringe assembly may thus be locked in the first position whereforward movement is restricted by the syringe lock, such as by theresting ledge. As the syringe lock is rotated, the syringe assembly maybe free to move forward and the syringe driver may thereby be releasedto move the syringe assembly from the first position to the secondposition. The forward motion may thus be restricted by the syringeassembly tab engaging a syringe lock end stop. A distance along thelongitudinal axis of the auto injector from the resting ledge to the endstop may thus indicate the travel of the needle from the first positionto the second position and thereby, the end stop may define theinsertion depth for the needle.

It is seen that the syringe lock may control the movement, such as theforward movement, and for example the movement from the first positionto the second position, of the syringe and/or the syringe assembly.Thus, the syringe lock may control the needle insertion.

The syringe assembly may comprise a syringe tube co-axially encompassingthe syringe and a plunger rod tube co-axially encompassing the plungerrod, the syringe tube and the plunger rod tube being interconnected viasyringe tube connectors engageable with plunger rod connectors.

The plunger rod driver may in one end be fixedly connected to a back endof the plunger rod tube and in another end be configured to engage theplunger rod. The plunger rod driver may be locked while the syringeassembly is moved from the first position to the second position, andthus, the plunger rod may be kept in the same position while the syringeassembly is moved from the first position to the second position. Thus,the plunger rod driver, the plunger rod and the plunger rod tube may bemoved forward by the syringe driver.

The plunger rod may be configured to be released when the syringeassembly is in the second position thereby activating the plunger roddriver to move the plunger rod forward. Hereby, the plunger rod mayengage the syringe stopper and thereby forcing the syringe stopperforward and deliver a dose of medicament. The plunger rod may typicallymove forward a predetermined distance in the syringe before a plungerrod stop engages the plunger rod and prevents further forward movementof the plunger rod. The predetermined distance may indicate the amountof medicament delivered, depending on syringe size.

The plunger rod driver may be configured to move the plunger rod a firstpredetermined distance upon a first activation of the plunger roddriver, a second predetermined distance upon a second activation of theplunger rod driver, a further predetermined distance upon a furtheractivation of the plunger rod driver, etc., before engaging a firstplunger rod stop, a second plunger rod stop and/or any further plungerrod stops. The first, the second and/or further predetermined distancesmay be different distances to allow for different doses of medicament tobe delivered following first, second and/or further activations of theauto injector.

The second or further activation of the plunger rod driver may follow areload of the auto injector, and thus follow any movement of the syringeassembly from the first position to the second position. The movement ofthe syringe assembly from the first position to the second position maythus comprise moving the plunger rod, the plunger rod driver and theplunger rod tube with the syringe assembly. Thereby, the plunger rod mayremain locked upon any plunger rod stop, and the plunger rod driver maynot be able to drive the plunger rod forward while moving the syringeassembly from the second position to the first position. The plunger rodmay, after a first injection cycle has been completed, not be releaseduntil the syringe assembly, following activation of the auto injector,is moved from the first position to the second position a second and/orfurther time.

In one or more embodiments, the user operation of the reload handle, soas to for example activate the auto injector and thereby ready the autoinjector for a second and/or further delivery of medicament, maycomprise a rotational movement.

The reload handle may be configured for a rotational movement, and theauto injector may further comprise an intermediate component, such as atorsion ring, transferring the rotational movement of the reload handleto a translational movement of at least the syringe assembly.

The intermediate component which may be interconnected to the syringeassembly may have a tab configured to move longitudinally along a guideor surface of the reload handle to thereby retract the syringe assemblyfrom the second position to the first position upon user operation ofthe reload handle. The guide or surface of the reload handle may in someembodiments be an inclined guide or surface of the reload handle, andthe tab may move along the inclined surface upon operation of the reloadhandle. Thereby, the syringe assembly may be forced along the inclinedsurface to move the syringe assembly from the second position to thefirst position, and may further rotate the syringe assembly. Hereby, thesyringe assembly may follow the guide in the syringe lock into the firstposition.

A complete operation of the reload handle may force the tab on theintermediate component over an inclined surface top and into a second orfurther reload handle slot. Thus, after the retraction of the syringeassembly, the syringe assembly is further rotated. This rotationalmovement may allow for the syringe assembly to be rotated onto thesyringe lock ledge and lock the syringe assembly in the first positionand thereby ready the device for a further delivery. Thus, when theintermediate component tab reaches the second or further reload handleslot, the syringe assembly is rotated onto the syringe lock ledge.

The second and/or any further reload handle slots may have an inclinedsurface to allow for continuous reloading of the auto injector. In oneor more embodiments, the reload handle comprises two inclined reloadhandle slots to allow for continuous reloading of the auto injector.

The second reload handle slot may be a slot substantially parallel witha longitudinal axis of the auto injector, with no inclined surface tops,thus, the second and/or further reload handle slot may allow forlongitudinal movement only to thereby prevent further reload of the autoinjector. Thus, the reload handle may not be able to reload the autoinjector and ready it for a further injection as the intermediatecomponent will not be able to translate the rotational movement of thehandle to translational movement of the syringe assembly.

The reload operation may be configured to reverse the operation of theauto injector and may for example reverse syringe driver, syringe lock,skin sensor, etc.

In one or more embodiments, the auto injector housing may furthercomprise an indication of a “ready” state and a “not ready” or “done”state. The “ready” state may indicate a first rotational position of thesyringe lock in which position the syringe assembly is locked in thefirst position. As the syringe assembly may be rotated upon injectionwith respect to the housing, and further moved forward with respect tothe housing, the “ready” state may not be shown in the window unless thesyringe assembly is in the first locked position. The “ready” state mayfurthermore only be indicated to an operator or a patient when the skinsensor is in the unlocked state. Thus, the “ready” state may indicatethat the auto injector is ready to use when unpacked, and indicate thatthe auto injector is ready to use after reloading of the auto injector.

The indication may be provided as a label window which may revealinformation provided in for example the syringe lock or any otherstructural element beneath the housing in which a “ready” state isindicated, either by inscription, by color coding, etc. The indicationmay also be provided be an inspection window which may be a windowprovided so that the drug or medicine in the syringe is visible when theauto injector is in the ready state, and wherein the view of the drug ormedicine is obscured when the auto injector is in any “not ready” or“done” state.

The inspection window may further provide a view of the medicine beforethe auto injector is used for injection of medicine to thereby provide avisible check of medicine availability, medicine color, quality, etc.

The skin sensor and/or needle shield may extend over the length of theneedle when the syringe assembly is in the first position to hide theneedle from a patient's or user's view and the skin sensor and/or needleshield may further be configured to extend over the length of the needleas the needle is withdrawn after a dose has been delivered.

In one or more embodiments, the auto injector may be configured toprovide a sound while delivering a medicament, so that a sound isgenerated while dosing by e.g. a sound generator. The sound may begenerated during the entire delivery of a dose, or the sound may begenerated during at least a part of the delivery of the dose, such asduring more than 50% of the time of delivery, during the last third ofthe time of delivery, during substantially the entire time of delivery,etc. Thus, the auto injector may further comprise a sound generatorconfigured to emit a sound while dosing, and in some embodiments, thesound generator may comprise a ratchet mechanism. The ratchet mechanismmay be any conventional ratchet mechanism, such as a ratchet mechanismcomprising flexible arms positioned with the syringe assembly forengaging sloped teethes on the plunger rod, for example such as to allowfor forward movement only of the plunger rod.

Typically, when delivering a medicament with an injector, it isadvantageous to keep the needle in place under the skin for a period oftime after the injection has taken place. Hereby, the uptake of themedicament may be improved significantly, and furthermore, the risk ofthe medicament leaking out of the injection site may be reduced.However, for a patient or a user, it may be difficult to tell when theinjection has been completed and thus from when the period of time afterinjection should be determined.

In some prior art embodiments, a sound has been generated after the dosehas been injected, i.e. after the injection cycle has been completed,however, for a patient or a user, this means that there are three phasesduring the injection; first a silent phase while the medicament isinjected, than a sound phase, i.e. the end-of-dose signal, and thenagain a silent phase in which the patient or user has to keep the needleunder the skin. For a patient or user, especially a user under stress,which may be the case if it is an emergency injection of medicament,this may be difficult to administer.

It is therefore an advantage of generating a sound during at least apart of the delivery of the dose, to thereby indicate with a sound whenmedicament is injected, that is, the sound is provided while dosing, andwhen the sound stops, the user may have to keep the needle under theskin for a period of time. This results in only two phases, an injectionphase with sound, and a silent phase in which the user may have to keepthe needle under the skin and this procedure may be simpler toadminister for a user.

To generate the sound while dosing, a sound generator or noise maker,such as a ratchet mechanism, may be integrated with the auto injector.

For example, the plunger rod may be a linear ratchet having a number ofteeth configured to interact with a number of pawls provided inconnection with the plunger rod tube, so as to generate a sound whilethe plunger rod is extended passed the pawls. The ratchet mechanism maycomprise flexible arms positioned with the syringe assembly for engagingsloped teeth on the plunger rod.

A ratchet mechanism inherently allow movement in one direction only,thus providing a ratchet mechanism with the plunger rod allow formovement in a forward direction only, and may prevent the plunger rodfrom being returned to its initial position. Thus, the sound generatormay further act as an anti-tampering component, in that the ratchetmechanism ensures that a used auto injector may not be separated and beretro-fitted with another syringe for a new patient or user as theplunger rod cannot be retracted from the syringe into the initialposition.

In one or more embodiments, the syringe assembly may further comprise ananti-tamper component, such as a tamper protection, and the anti-tampercomponent may for example comprise protection mechanism to ensure thatbackward movement of the plunger rod is prevented, such as a ratchetmechanism, such as a ratchet mechanism allowing for forward motion ofthe plunger rod only.

In one or more embodiments, the auto injector may be re-usable, thus, auser may be able to disassemble the auto injector to replace thesyringe. For example, a user may be able to replace the syringe withneedle only, or a user may be able to replace the syringe assembly witha new syringe assembly.

Typically, the auto injector may be provided in a casing and the casingmay have to be removed before the auto injector is ready to be used.

A medicinal cartridge or pre-filled syringe is typically provided with aneedle. To protect the needle during transportation and to enable sharpsprotection, the syringe needle is typically provided with a softprotective part and a rigid protective part, i.e. the rigid needleshield, RNS. To ready the auto injector for injection, typically, boththe soft protective part and the rigid protective part needs to beremoved. However, both for safety reasons, and because the protectiveparts may be difficult to access for a user, a rigid needle shieldremoval part may be implemented. The rigid needle shield removal partmay at least partly enclose the rigid protective part and for examplegrip a ridge on the rigid protective part so that the rigid protectivepart may be removed with the removal of the rigid needle shield removalpart.

The casing, such as a transportation housing, may be removed by forexample a straight pulling motion, a twist, a combination of these, orin any other way as known by a person skilled in the art. In someembodiments the casing may surround the syringe assembly, but not thereload handle. The casing may be held in place by a ring snap mechanismprovided between the reload handle and the casing. The casing and thereload handle assembly may be sealed by a piece of adhesive tape wrappedaround the casing and the reload handle assembly. The casing may beremoved from the auto injector by twisting the casing slightly againstthe reload handle, utilizing for example a tapered knob on the autoinjector to translate the rotational force into a longitudinallymovement which breaks, partly by the rotation and partly by the axialdisplacement in the longitudinal direction, the adhesive. Also due tothe longitudinal displacement the RNS removal part may start to pull offthe RNS where the remaining dismantling of the RNS is carried out by theoperator. The gearing by the rotation over the tapered knob helps theoperator to more easily overcome potential high stick-forces for the RNSafter longer time of storage, once moved a small distance the operatormay easily pull off the RNS the remaining distance at much less forceinput. The twisting of the reload handle relative to the casing maygenerate a longitudinal movement in any know way, e.g. by a tapered knobto translate the rotational force into a longitudinal movement, or by aninternal thread where unscrewing in one predetermined rotationaldirection would yield longitudinally separation between the handle andcasing, etc.

The RNS (Rigid Needle Shield) may cover the injection needle on thesyringe and may be pre-mounted on the syringe before assembling the autoinjector. The step of readying an auto injector for injection, maycomprise the step of removing the rigid needle shield whereby theinjection needle becomes exposed. In some embodiments, the removal ofthe RNS may be an integrated part of the auto injector device activationprocess and hence automated in view of the operator, user or patient.The RNS removal part may be provided so that the auto injector includingthe RNS is not tampered with during storage, and furthermore, the RNSmay be protected so that any significant physical dislocation from itsinitial sealing position of the RNS is avoided. Such physicaldislocation may be e.g. be a radial or a longitudinal displacement orcaused by rocking motions etc. and such physical dislocation may have aserious impact on auto injector performance. The process of removing theRNS may be robust and reliable but at the same time, the seal providedby the RNS should be efficient. Thus, the automated removal of the RNSupon device activation may ensure none or minimal physical interactionfrom outside forces to the RNS during the storage period. Still, upondevice activation the RNS removal may be highly robust as otherwise itmay potentially be difficult for the operator to gain access for manualremoval. Thus, the mechanism interfacing to the RNS may have to satisfytwo opposite requirements. Furthermore, the assembly of the autoinjector with the RNS removal part may be easy and intuitive.

In some embodiments, the RNS removal part may have a general cylindricalshape but may have slits along its side to allow for insertion of theentire RNS. Furthermore, the RNS removal part may have a U-shapedcut-out on the end surface towards the syringe in order to allow thepresence of the syringe, and the diameter/size of the U-shaped cut-outmay be designed to be smaller than the maximum diameter of the RNS butlarge enough to not be in physical contact during storage, i.e. nottouch upon syringe or upper portion of the RNS. With the RNS removalpart in place, a longitudinal force pulling away from the syringe willnow ensure engagement between RNS removal part and the larger diameterrime on the RNS and may thereby force the RNS to be pulled off of thesyringe.

The RNS removal part may be applied sideways to the RNS and syringeassembly, or the RNS removal part may be applied longitudinally, therebypushed onto the RNS and syringe assembly from the front. A number ofextended hooks may grip behind the RNS to facilitate pulling off of theRNS by exertion of pull forces on the RNS removal part. In anotherembodiment, a number of deflectable extended fingers with hooks to reachbehind the RNS may be envisioned both allowing for sideways assembly orlongitudinal or axial assembly.

In one or more embodiments, the RNS removal part may furthermorecooperate with the skin sensor so that e.g. deflectable parts, such asdeflectable finger hooks, may be forced inside the skin sensor duringremoval through a tight diameter fit. For example, the skin sensor mayhave an internal diameter, such as 12 mm, to just allow the hooks topass through but any potential radial deflection of the hooks, i.e. whensubjected to the stress exerted from the pulling force, may be minimizeddue to marginal available space between the deflectable parts outerradial extension (diameter) and the inner diameter of the skin sensor.

The present invention will now be described more fully hereinafter withreference to the accompanying drawings, in which exemplary embodimentsof the invention are shown. The invention may, however, be embodied indifferent forms and should not be construed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art. Likereference numerals refer to like elements throughout. Like elementswill, thus, not be described in detail with respect to the descriptionof each figure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exploded view of an auto injector,

FIGS. 2A-G show exemplary a view of the auto injector in various statesas seen from a user perspective,

FIGS. 3A-C show indicators in different states,

FIGS. 4A-C show an auto injector handle top and corresponding casing,

FIGS. 5A-E show a rigid needle shield remover component,

FIGS. 6A-E show a cross sectional view of an auto injector according tothe invention during different stages of operation,

FIGS. 7A-N show a reload handle, plunger rod tube and plunger rod invarious stages,

FIGS. 8A-C show details of a skin sensor,

FIGS. 9A-F show a reloading mechanism according to the presentinvention,

FIGS. 10A-E show a syringe lock guiding trail in various stages,

FIGS. 11A-B show a detailed view of an inspection window,

FIGS. 12A-C show a sound generator,

FIGS. 13A-B show a reload handle for single or repeated delivery ofdoses,

FIG. 14 shows a syringe assembly in more detail

FIG. 15 shows another auto injector according to an embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE DRAWING

In the following an auto injector according to any of the abovedescribed aspects of the invention will be described in more detail andwith reference to the drawings. A reloadable auto-injector 10 with ahousing 400 for accommodation of a syringe assembly 20 is provided. Thesyringe assembly 20 may comprise a syringe 900 with a needle 902, andthe syringe assembly 20 may be movably positioned in the housing 400between a first position in which position the needle 902 isaccommodated inside the housing 400 and a second position in whichposition the needle 902 protrudes outside the housing 400. The syringeassembly 20 may further comprise a syringe stopper 908 movablypositioned in the syringe 900 and sealing syringe content 904, a plungerrod 1500 configured to engage the syringe stopper 908, and a plunger roddriver 1600 being configured to apply a force to the plunger rod 1500 toadvance the plunger rod 1500 in the syringe 900 for delivering at leastone dose of medicament. Furthermore, a syringe driver 1200 may beaccommodated inside the housing 400 and be configured to apply a forceto the syringe assembly thereby moving the syringe 900 from the firstposition to the second position. The housing 400 may still furthercomprise a reload handle 1400 configured to reload the auto injector 10for injecting a further dose of medicament, wherein the reload handle1400 may be connected to the syringe assembly so that user operation ofthe reload handle 1400 is configured to retract the syringe assembly tothe first position and to simultaneously reload the syringe driver 1200to thereby ready the auto injector for delivering a further dose ofmedicament.

In FIG. 1 an exploded view of a syringe driver according to anembodiment of the present invention is provided. A casing 100 isprovided as a transport casing and is configured to be removed by theuser before use of the auto injector 10. The rigid needle shield removalpart 200 preferably cooperates with the casing 100 and the rigid needleshield 300 so that the rigid needle shield may be easily removed withthe casing 100.

The auto injector has a housing 400 configured to enclose the furtherauto injector parts, including the syringe lock 500 and the skin sensor600 which parts cooperate to release and lock the needle shield and thesyringe assembly. The skin sensor driver 700 may be a spring. Thesyringe tube is provided to accommodate the syringe 900 with needle 902,and is interconnected to the plunger rod tube 1100. A sound generator1000 is positioned in-between the syringe 900 and the plunger rod tube1100. A syringe driver 1200 is configured to act on the syringe 900 inthe syringe tube 800. Housing lock ring 1300 interconnects the housing400 and reload handle top 1800. The handle 1400 is interconnected withthe handle top 1800 and allows for reloading of the device, inco-operation with syringe lock 500 and skin sensor 600 as furtherdescribed below. The plunger rod 1500 comprises a plurality of teeth1502 configured to generate sound while moving in relation to soundgenerator 1000. Plunger rod driver 1600 is configured to apply a forceto the plunger rod 1500. Torsion ring 1700 transmits the rotationalmovement of the handle top to a translational movement of the syringeassembly. Handle top 1800 is positioned at an end of the auto injector10, and is configured to be rotated with respect to the housing 400 uponreloading of the device.

FIG. 2 illustrates the auto injector in various use states as seen fromthe point of the user or patient. In FIG. 2A, the auto injector isenclosed in casing 100 and the casing 100 is adjoining handle top 1800.In FIG. 2B, the casing 100 is removed and auto injector 10 has becomevisible. The auto injector 10 comprises housing 400 having an inspectionwindow 402 and a skin sensor 600. A medicament 904 in the syringe 900 isvisible through the inspection window 402, as indicated by the darkcolor of the window thereby indicating to a user that the auto injectoris ready to use. The handle top 1800 is configured to interact withreload handle 1400 which is partly visible below the handle top 1800 inFIG. 2B. The skin sensor 600 is in an extended forwards position,completely shielding the needle. In FIG. 2C, the skin sensor is pushedslightly backwards in relation to the skin of a patient, and the needle902 is visible in the skin sensor opening 602. The automatic needleinsertion is not yet activated. In FIG. 2D, the skin sensor 600 ispushed backwards and is in the retracted position, and the automaticneedle insertion has been activated so that needle 902 protrudes fromthe skin sensor and the tip of the syringe 900 is visible in the skinsensor opening 602. In this position, the needle is configured to beinserted into the skin of a patient. When the user removes the needle902 from the skin after injection, the skin sensor 600 is pushed forwardand shields the needle 902. The needle sensor is in a locked position.It is seen that in neither of the FIGS. 2C to 2E is the medicamentvisible through the inspection window 402 thereby indicating to a userthat the device is not in an initial position ready to deliver a dose.In FIG. 2F, the auto injector 10 is re-loaded by turning the handle top1800 with respect to the housing 400, the skin sensor is in an unlockedposition and the medicament 904 in the syringe 900 is visible throughthe inspection window 402. In FIG. 2G, the skin sensor is in a lockedposition after a second dose has been delivered, and the inspectionwindow 402 indicates that the device is not in a ready position.

In FIG. 3, indicator windows 402, 404 are provided. The inspectionwindow 402 and the label window 404 of auto injector 10 is shown in moredetail. In FIG. 3A, the auto injector is in a ready state with the capand casing removed. The inspection window is open and thus exposes themedicament 904 in the syringe 900 and the skin sensor driver 700 isfurthermore visible through the window. It is seen that the skin sensoris in the unlocked forward position and the device is ready to deliver adose, as is also indicated by label window 404 reading “READY”. In FIG.3B, the needle 902 has been injected into a patient's skin 1900. Theskin sensor is fully retracted and the housing 400 is resting on thepatient's skin 1900. The inspection window is closed and does not revealthe medicament, and the label window has the reading “DONE” when thedose has been injected. In FIG. 3C, the skin sensor is fully extendedand is in the locked forward position and skin sensor lock tabs 608 arevisible. The inspection window is closed and the label window still hasthe reading “DONE”. It is seen that during the injection process, theneedle 902 is not visible for the user or the operator activating theauto injector and the skin sensor also acts as a needle shield or needleshroud. It is seen from the FIGS. 2 and 3 that the overall length of theauto injector is not significantly increased when delivering a furtherdose and it is an advantage of the present invention that a compact autoinjector is provided which is capable of delivering one or more doses.The compact size is obtained due to the reversible features of the autoinjector as further described below.

FIG. 4 shows the mechanism for removing casing 100 in more detail. Asseen in FIG. 4A, the casing 100 is adjoining the handle top 1800. Thecasing may be held in place by a ring snap mechanism in place betweenthe handle 1400 and the casing 100. The casing 100 and the handle top1800 may be sealed by a piece of adhesive tape (not shown) wrappedaround the casing 100 and handle top 1800 assembly. Upon activation,that is when the user unpack the auto injector 10, the casing 100 isremoved from the auto injector 10 by twisting it slightly against thehandle top 1800, utilizing a tapered knob 1402 on the auto injector,such as on the reload handle 1400 to translate the rotational force intoa longitudinally movement which breaks the adhesive as shown in FIG. 4B.In FIG. 4B, in which the casing is slightly turned to break the seal anddisengage the ring snap mechanism. The casing 100 is removed partly bythe rotation and partly by the longitudinal displacement following boththe longitudinal movement initiated by the tapered knob 1402 and apulling action initiated by the user.

In FIG. 5, The RNS (Rigid Needle Shield 300 covers the stacked injectionneedle 902 on the syringe 900 and is typically pre-mounted on thesyringe 900 before entering a device assembly line. To ready the autoinjector 10 for injection, the rigid needle shield needs to be removedto expose the needle. The removal of the RNS 300 is an integrated partof the auto injector activation process and hence automated in view ofthe operator or user. The RNS removal part 200 may be provided so thatthe auto injector 10 including the RNS 300 is not tampered with duringstorage. Preferably, the RNS 300 may be protected so that anysignificant physical dislocation from the initial sealing position ofthe RNS 300 is avoided. Such physical dislocation could be e.g. a radialor a longitudinal displacement and could be caused by rocking motionsetc. These physical dislocations could have a serious impact on autoinjector performance and could e.g. bend the injection needle 902. Theprocess of removing the RNS 300 needs to be robust and reliable but atthe same time, the seal provided by the RNS 300 should be efficient.Thus, the automated removal of the RNS 300 upon activation or unpackingof the auto injector 10 may ensure none or minimal physical interactionfrom outside forces to the RNS 300 during the storage period. Still,upon device activation the RNS removal may be highly robust as otherwiseit may potentially be difficult for the operator to gain access formanual removal. Thus, the mechanism interfacing to the RNS 300 have tosatisfy two opposite requirements. Furthermore, the assembly of the autoinjector with the RNS removal part 200 should be easy and intuitive.

In FIG. 5A, the parts are shown in detail and the RNS removal part 200has a general cylindrical shape and has slits 202 along its side toallow for insertion of the entire RNS 300. Furthermore, the RNS removalpart 200 has a U-shaped cut-out 204 on the end surface towards thesyringe 900 in order to allow the presence of the syringe 900, and thediameter/size of the U-shaped cut-out 204 may be designed to be smallerthan the maximum diameter of the RNS 300 but large enough to not be inphysical contact during storage, i.e. not touch upon syringe 900 orupper portion of the RNS 300. With the RNS removal part 200 in place, alongitudinal force pulling away from the syringe will now ensureengagement between RNS removal part 200 and the larger diameter rime onthe RNS 300 and may thereby force the RNS 300 to be pulled off of thesyringe 900.

The RNS removal part 200 is in the present embodiment applied sidewayswith respect to the RNS 300 and syringe assembly 900, and FIG. 5B showsthe RNS removal part 300 applied sideways to the RNS 300. In thisembodiment, the RNS removal part 200 does not comply with the otherwiseaxially stacked assembly of the auto injector. FIG. 5C shows the syringe900 with the RNS removal part 200 and the skin sensor 600 mounted oncircumferential to the RNS removal part 200.

To benefit from the described RNS removal part 200, a fixation betweenthe RNS removal part 200 and the casing 100 is suggested by heatstacking. In FIG. 5D, a cross section of the interface between casing orcap 100 and the RNS removal part 200 is shown as mounted, the RNSremoval part tip 206 is shown extending beyond the casing 100. In FIG.5E, it is seen that heat stacking has been applied and the RNS removalpart tip 206 has been deformed to fixation part 208. It is howeverenvisaged that any other means of fixation would be possible, e.g. ascrew or a rivet, using ultrasonic welding etc.

Due to the fixation between the rigid needle shield removal part 200 andthe casing 100, the RNS removal part will move when the casing is moved.Thus, due to the longitudinal displacement initiated by the twisting andpulling action applied to the casing 100 with respect to handle top1800, the RNS removal part 200 will start to pull off the RNS 300 wherethe remaining dismantling of the RNS 300 is carried out by the operatoror user. The gearing by the rotation over the tapered knob 1402 helpsthe operator or user to more easily overcome potential high stick-forcesfor the RNS 300 after longer time of storage; once the RNS 300 has beenmoved a small distance, the operator may easily pull off the RNS 300 theremaining distance, to free the needle 902 completely, at much lessforce input. It is envisaged that also other way of generating alongitudinal movement from rotation may be used instead of tapered knob1402, e.g. by an internal thread where unscrewing in one predeterminedrotational direction would yield longitudinal separation between thehandle and casing. Use of the tapered knob 1402 has an advantage overinternal hidden features in that it helps during assembly of theauto-injector device as there is a visually clear rotational orientationfor the two parts to meet.

FIG. 6 shows a cross sectional view of an auto injector in a number ofinjection stages. In FIG. 6A, the auto injector is in a storing stage.The auto injector 10, apart from the handle top 1800 is encompassed incasing 100. The RNS 300 and the RNS removal part 200 are in position toprotect the needle 902 and facilitate removal of the RNS, respectively.The plunger rod 1500 is in an initial position and a forward end 1510 ofthe plunger rod 1500 is positioned at a distance from a syringe stopper908 surface. Thereby, a slight accidental movement of the plunger rod1500 will not impact the syringe stopper 908.

In FIG. 6B, the auto injector is shown immediately after the injectionof a first dose. The needle 902 is exposed and inserted into the skin ofa patient (not shown) and the plunger rod 1500 has been moved forwardunder influence of plunger rod driver, i.e. spring, 1600, so that theprotrusion 1508 of the plunger rod rests against a first stop 1102 ofthe plunger rod tube 1100, see further details in FIG. 7. The stopper908 has been moved forward to expel a first dose of medicament and theskin sensor 600 is the retracted position.

After the needle 902 has been retracted from the skin, in FIG. 6C, theskin sensor 600 is moved to a forward locked position by skin sensordriver 700. At the stage C in FIG. 6C, the auto injector may be eitherdiscarded as it is or reloaded for delivering of a second or furtherdose.

FIG. 6D shows the auto injector 10 after reloading of the device: Theplunger rod 1500 has been moved forward under influence of plunger roddriver, i.e. spring, 1600, so that the protrusion 1508 of the plungerrod rests against a second stop 1104 of the plunger rod tube 1100, seefurther details in FIG. 7. The stopper 908 has been moved forward toexpel a first dose of medicament and the skin sensor 600 is theretracted position.

The skin sensor 600 has been unlocked and is in the forward unlockedposition, the syringe driver 1200 has been reloaded, i.e. retracted,into an initial compressed position and the syringe 900, the syringetube 800, the plunger rod tube 1100, the plunger rod 1500 and theplunger rod driver 1600 have been retracted without moving the mentionedparts in relation to each other.

In FIG. 6E, a second or further injection has been made. The plunger rod1500 has been moved forward under influence of plunger rod driver, i.e.spring, 1600, so that the protrusion 1508 of the plunger rod restsagainst a second stop 1104 of the plunger rod tube 1100, see furtherdetails in FIG. 7. The stopper 908 has been moved forward to expel asecond or further dose of medicament. The skin sensor 600 is in theforward locked position and the auto injector may be discarded, afurther injection may be performed or the auto injector may be re-usedby for example re-fitting the auto injector with a new pre-filledsyringe.

In FIG. 6, it is seen that the plunger rod driver 1600 comprises aplunger rod spring 1600. The plunger rod spring 1600 is in one end 1602fixedly connected to the plunger rod tube 1100. It is seen that theplunger rod driver 1600 applies the driving force directly onto theplunger rod 1500, such as onto a plunger rod flange 1508, i.e. theplunger rod protrusion 1508. In FIG. 6, it is seen that the plunger roddriver acts on the top of the plunger rod flange 1508 whereas the otherside of the plunger rod flange 1508 normally locks the plunger rod 1500to the plunger rod tube 1100, in that the plunger rod stop 1508 presseson the locking member 1108, i.e. presses on the plunger rod tube stop1102.

The housing further accommodates a syringe tube for holding the syringe,and the syringe has a syringe flange which is locked between the syringetube and the plunger rod tube. In the present example, the syringe tubeand the plunger rod tube are provided as two separate units to easeassembly, however, it is envisaged that the syringe tube and the driverrod tube may be one tube holding the syringe, the plunger rod and theplunger rod driver.

It is seen that the plunger rod driver is provided inside the plungerrod tube, and the syringe driver is provided outside the plunger rodtube.

In FIGS. 7a-l , a reload handle and the cooperation with the plunger rodtube and the plunger rod is shown. Only a top portion 30 of an autoinjector as e.g. seen in any of the FIGS. 1-6 above or any of thefigures is seen in FIG. 7. The auto injector as shown in FIG. 7, iscapable of sequentially control the needle insertion and dose injection.The function of the sequential control is illustrated in stages Athrough L. FIGS. 7A, 7C, 7E, 7G, 7I and 7K shows the reload handle 1400,the plunger rod tube 1100 and the plunger rod 1500 in various stages ofthe process, and FIGS. 7B, 7D, 7F, 7H, 7J and 7L show a cross-sectionalview of the auto injector in the stages A, C, E, G, I and K.

The plunger rod 1500 is configured to be advanced in the syringe (notshown in FIG. 7) for delivering at least one dose of medicament. Theplunger rod tube 1100 has a least one locking member 1108 configured tointeract with a plunger rod stop 1508 to normally lock the plunger rod1500 to the plunger rod tube 1100 (see FIGS. 7M, 7N).

The syringe driver 1200 is not shown in FIG. 7, however the activationof the syringe driver is illustrated by the arrows 42, 44, that is theplunger rod tube 1100 and the plunger rod 1500 are both moved forwards,i.e. from the first position to the second position. The plunger roddriver 1600 is not shown in FIG. 7, however, the activation of theplunger rod driver 1600 is illustrated by single arrow 42 illustratingthat only the plunger rod is moved forward, i.e. the force applied bythe plunger rod driver 1600 forces the plunger rod 1500 to advance inthe syringe (not shown) for delivering at least one dose of medicament.It is seen that the housing 400, or in the present case an intermediateelement 1400, i.e. the reload handle 1400, comprises an opening or anaperture 1420. The housing or intermediate element 1400 is configured tounlock the locking member 1108 and release the plunger rod 1500 from theplunger rod tube 1100 when the syringe (not shown) and the plunger rodtube 1100 is advanced to the second position, thereby activating theplunger rod driver (not shown) to advance the plunger rod 1500 in thesyringe for delivering of at least one dose of medicament.

The locking member 1108 may be referred to as a deflectable lockingmember 1108 and the housing 400 and/or the intermediate member 1400 isconfigured to allow for the deflectable locking member 1108 to deflectaway from the plunger rod 1500 when the syringe (not shown) and theplunger rod tube 1100 is advanced to the second position. Thus, it isseen in FIGS. 7A, 7B that the plunger rod 1500 in the plunger rod tube1100 is in an initial position, i.e. a first position, ready to delivera dose of medicament. In the second position after forwards movement ofthe plunger rod tube 1100 and the plunger rod 1500, the plunger rod tubeis in the second position. It is seen in FIGS. 7C and 7D, that theplunger rod 1500 has not been moved with respect to the plunger rod tube1100 and both the plunger rod tube 1100 and the plunger rod 1500 hasbeen moved forwards relative to the housing or intermediate member 1400.The plunger rod driver is typically positioned inside the plunger rodtube 1100 circumferentially around a backward end 1512 of the plungerrod 1500 configured to apply a force to the plunger rod protrusion 1508.The backward end 1512 may have a reduced diameter, i.e. a diameterreduced relative to the diameter of other parts of the plunger rod, suchas for example relative to the forward end of the plunger rod 1510.

The plunger rod tube 1100 and the syringe (not shown) are typicallyinterconnected so that the plunger rod tube 1100 cannot move withrespect to syringe 900 and vice versa. The plunger rod tube 1100 may beinterconnected to the syringe 900 or the syringe tube 800, for examplevia plunger rod tube tabs 1112.

The housing has an opening 1420, the opening 1420 being a window, or anaperture, configured to be aligned with the at least one deflectablemember when the plunger rod tube is advanced to the second position. InFIG. 7D, it is seen that the first deflectable locking member 1108 isaligned with the window or aperture 1420 thereby allowing the lockingmember 1108 to deflect and allow passage of the plunger rod protrusion1508, such as the plunger rod stop 1508.

It is seen in FIG. 7E that upon release of the plunger rod 1500, theplunger rod driver 1600 advances the plunger rod 1500 within the syringe900 in that the plunger rod stop 1508 is able to pass the deflectedlocking member.

A deflectable locking member 1108, 1110 is positioned at either side ofthe plunger rod as seen in FIG. 7B, and thus also the openings 1420,1422 are provided on either side.

In FIG. 7G, the handle 1400 is rotated as illustrated by arrow 1401 andthe plunger rod tube 1100 with plunger rod 1500 is rotated and retractedto the same initial position as illustrated in FIG. 7A, while theplunger rod maintain the advanced position with respect to the plungerrod tube, and the plunger rod driver (not shown in FIG. 7) alsomaintaining a first extended position. From this position, a second dosedelivery is performed, and FIGS. 7I and 7J illustrate the repeatedforward motion of the plunger rod tube with the plunger rod, asillustrated by arrows 42, 44 so as to align the second window 1422 withthe second deflectable locking member 1110 and allow deflection of thelocking member 1110. Thereby, the plunger rod driver 1600 is released oractivated to push the plunger rod 1500 pass the second locking member1110, for delivering of a second dose as illustrated by single arrow 42,and FIGS. 7K, 7L illustrates the plunger rod in the advanced positionwithin the syringe. The plunger rod driver is thus configured to movethe plunger rod 1500 a first distance upon a first activation of theplunger rod driver 1600, and a further distance upon a furtheractivation of the plunger rod driver 1600.

It is seen that the second activation of the plunger rod driver followsa reload of the auto injector, and thereby a repeated movement of thesyringe assembly 20, i.e. such as syringe 900, syringe tube 800, plungerrod 1500, and plunger rod tube 1100 from the first position to thesecond position.

Thus, the auto injector may deliver at least one or two separate dosesof medicament.

It is seen in FIGS. 7M, 7N that the plunger rod stop has an angledsurface 1509 normally pressing against an angular surface 1109 of thedeflectable locking member 1108. The deflectable locking member 1108,1110 is hinged to the plunger rod tube 1100 in a downward position withrespect to the movement of the plunger rod. Hereby, the deflectablelocking member may deflect only when the entire length of thedeflectable locking member 1108, 1110 opposes the full opening 14.

The at least one deflectable member is configured to deflect upon beingaligned with the opening in the housing 400 and/or the intermediatemember 1400.

When the deflectable locking members 1108, 1110 are not aligned with thewindow 1420, the deflectable locking members 1108, 1110 are typicallyprevented from deflection by an inner surface 1424 of the handle 1400 orhousing 400, and it is seen in FIG. 7N that the deflectable lockingmember 1108, 1110, is not entirely within the window 1420, 1422 andtherefore not able to deflect.

The plunger rod tube 1100 may thus comprise at least a first and asecond locking member 1008, 1110 configured to engage with the plungerrod stop 1508.

FIG. 8 shows the skin sensor 600 and the interaction of the skin sensor600 with syringe lock 500 in more detail. In FIG. 8A, the skin sensor600 and the syringe lock 500 are in their initial positions, and theskin sensor 600 is thus in the forward unlocked position. A protrusion604 having an angled surface 606 is seen at the skin sensor 600. In FIG.8B, the skin sensor 600 is activated, by e.g. pressing the skin sensor600 against the skin of a patient, and the skin sensor 600 is movedtowards the syringe lock 500. Hereby, the angled surface 606 engageswith a syringe lock angled surface 512 to thereby force the syringe lock500 to rotate while the skin sensor 600 is retracted. In FIG. 8C, theskin sensor 600 is fully depressed, i.e. fully retracted, and engagedwith the syringe lock after rotation. FIG. 8D shows a detailed view ofthe syringe lock protrusion 604 and the angled surface 504 of thesyringe lock 500.

In FIG. 9, a reloading mechanism is shown in more detail. In FIG. 9A(bottom of the figure), the syringe 900 with needle 902 is seenprojecting from syringe tube 800 in a first end, such as a forward end,804. The syringe tube 800 is engaged with plunger rod tube 1100 and tabs1110 on the forward end 1101 of plunger rod tube 1100 engages with thesyringe tube 800 to interconnect the plunger rod tube 1100 and thesyringe tube 800. Typically, during assembly, the pre-filled syringe 900with needle 902 will be inserted into syringe tube 800 and plunger rodtube 1100, comprising plunger rod 1500 and plunger rod driver 1600, willbe mounted onto the syringe 900 and syringe tube 800 and the lips 910 ofthe syringe will be locked between the syringe tube 800 and plunger rodtube 1100. A tab 1112 on the plunger rod tube 1100 is configured tointeract with syringe lock 500 (see FIG. 10 for further details). Thesyringe tube 800 has a syringe tube inspection window 802 configured tointeract with syringe lock inspection window 502 and housing inspectionwindow 402. Syringe tube protrusions 806 may interact with skin sensor600 and provide an initial force which must be overcome by the user whenactivating the auto injector. This is a further safety feature whichreduces the risk of accidental activation of the auto injector.

Reload handle 1400 is slided onto plunger rod tube 1100 and torsion ring1700 interconnects reload handle 1400 and plunger rod tube 1100 viatorsion ring tab 1702.

In FIG. 9A, a first dose has been delivered and it is seen that torsionring tab 1702 is provided in a first reload handle slot 1404, and thetorsion ring tab 1702 has moved forwards along slot side 1406 and ispositioned at the bottom of the first reload handle slot 1404.

The reload handle 1400 as well as torsion ring 1700 may be symmetric, soas to evenly distribute the force applied, and that there is thus atorsion ring tab 1702 provided symmetrically on each side of the torsionring, each torsion ring tab 1702 interconnecting each of the firstreload handle slots provided symmetrically about the reload handle slot.

In FIG. 9B, the reload handle 1400 is rotated as indicated by arrow1401, thereby forcing the torsion ring which cannot rotate itself, alongthe inclined slot side 1408 via torsion ring tab 1702. In FIG. 9B, it isseen that the torsion ring tab 1702 has moved slightly along theinclined slot side 1704 after having rotated the reload handle slightly,e.g. about 30 degrees, as seen by the rotation of the reload handletapered knob 1402. This pulls the syringe assembly comprising thesyringe 900, syringe tube 800, plunger rod tube 1100, as well as plungerrod 1500 and plunger rod driver 1600 (not shown in FIG. 9) backwards andinto the reload handle 1400 as illustrated by arrow 24.

In FIG. 9C, the reload handle is further rotated, e.g. rotated 45degrees in total, and the torsion ring tab 1702 has moved towards thetop edge 1410 of the first reload handle slot 1404 further retractingthe syringe assembly 20 comprising syringe 900, syringe tube 800,plunger rod tube 1100, as well as plunger rod 1500 and plunger roddriver 1600 (not shown in FIG. 9) backwards and further into the reloadhandle 1400. While rotating the reload handle 1400 the plunger rod tubetabs 1112 also rotates towards a resting ledge 506 of the syringe lock500, as may be seen from FIG. 10.

As seen in FIG. 9D, continued rotation of the reload handle 1400 liftsthe torsion ring tab 1702 together with torsion ring 1700 and syringeassembly 20 over the top edge 1410 of the first reload handle top 1400and into second reload handle slot 1414. The torsion ring 1700 includingthe torsion ring tab 1702 and the syringe assembly will move forward ashort distance, such as a few mm, as indicated by arrow 22, before thesyringe assembly 20, and more specifically, the plunger rod tube tabs1112 hang on the syringe lock resting ledge 506. The auto injector 10 isthen in the initial position and ready to deliver a second or furtherinjection. In that the second reload handle slot is a slot allowing onlyfor movement longitudinally along an axis of the auto injector, the autoinjector is locked after having delivered a second dose, and the autoinjector is thus not configured to deliver more than two doses. Thus,the auto injector may deliver no more than two doses. Also, alternativeconfigurations have been envisaged and this is shown in further detailin FIG. 13.

FIGS. 9E and 9F illustrates an alternative reload function in which thereload system relies on a longitudinal retraction of the syringeassembly 20, and FIG. 9E illustrates the reload handle 1400 and torsionring tab 1702 position after a first injection has been delivered. InFIG. 9F, a longitudinal retraction of the syringe assembly 20 reloadsthe auto injector.

FIG. 10 shows a detailed view of the syringe lock guiding trail 504enabling the skin sensor 600 to rotate the syringe lock 500 and controlthe dosing mechanism. Initially, as seen in FIG. 10A, the spring loadedsyringe assembly 20 rests on a syringe lock resting ledge 506 in thesyringe lock 500 by plunger rod tube tabs 1112, restricting forwardmovement of the syringe assembly 20. The skin sensor 600 is in theunlocked forward position.

In FIG. 10B, the skin sensor is pressed against the skin of a patient,and the syringe lock is rotated as indicated by arrow 24. Hereby, thesyringe assembly 20 is lifted free of the syringe lock resting ledge506.

In FIG. 100, the syringe assembly 20 has moved downwards along syringelock guiding trail 504, pushing the syringe assembly 20 forwards causinginjection of needle 902. During injection of the needle, the syringelock is further rotated to align dosing clips with dosing windows toallow for injection of a medicament. After injection, as seen in FIG.10D, and as the needle 902 is retracted from the skin of a patient, theskin sensor 600 is pushed forward by skin sensor driver 700. At thispoint, the two clips of the skin sensor are resting on a shelf on thesyringe lock, locking them in position to protect the needle. In FIG.10E, the device is reloaded and the syringe assembly 20 is in theinitial position and the skin sensor 600 in the forward unlockedposition.

FIG. 11 shows a detailed view of the inspection window 402. In FIG. 11A,housing inspection window 402, syringe tube inspection window 802 andsyringe lock inspection window 502 are aligned and the medicament 904 inthe syringe 900 is visible. Furthermore, the skin sensor driver 700 isvisible through the housing inspection window 402 and the syringe lockinspection window 502. In FIG. 11B, it is seen that the inspectionwindows are not aligned and that only a part of the syringe lock 500 isvisible behind the housing inspection window indicating that the deviceis not ready for delivering an injection dose.

It is an advantage that a user or patient is able to see the medicamentthrough the inspection windows 402, 502 and 802 at the time of injectionof the medicament, as it gives the user a sense of what is injected.

In FIG. 12, a ratchet mechanism comprising a plunger rod 1500interacting with a sound generator 1000 is shown. The sound generator1000 comprises flexible arms 1002 positioned with the syringe assembly20 and configured to engaged sloped teeth 1502 of the plunger rod. Theupwardly sloped teeth 1502 on the plunger rod may allow forward movementof the plunger rod only.

It is seen that the ratchet mechanism 1500, 1502, 1000, 1002 isconfigured to provide a sound while delivering a medicament, so that asound is generated while dosing. The sloped teeth are provided along thelength of the plunger rod, and substantially along the entire length ofthe plunger rod so that the sound is generated during delivery of afirst dose and during delivery of a second dose and/or any furtherdoses. It is however envisaged that the sloped teeth may be distributedover only a part of the plunger length and for example be configured toonly generate a sound during delivery of the first dose, the seconddose, any further doses or a last dose of medicament from the syringe toindicate end-of-medicament in a syringe.

It is an advantage of generating a sound during at least a part of thedelivery of the dose, to thereby indicate with a sound when medicamentis injected, that is, the sound is provided while dosing, and when thesound stops, the user may have to keep the needle under the skin for aperiod of time.

The plunger rod 1500 as illustrated in FIG. 12 is thus a linear ratchethaving a number of sloped teeth 1502 configured to interact with anumber of flexible arms 1002 provided with the plunger rod tube 1100 soas to engage with the plunger rod 1500 when the plunger rod 1500 isadvanced forwards passing the flexible arms to thereby generate a sound.

In FIG. 12A, the plunger rod 1500 is shown in the plunger rod tube in aninitial position, i.e. before dosing. In FIG. 12B, a first dose ofmedicament has been delivered, and the plunger rod 1500 has moved in aforward direction a distance corresponding to the first dose. It is seenthat there is a sound delay while the plunger rod is moved from firststop 1506 to second stop 1504, indicating that the sound only starts,when the stopper 908 is moved forward and is delivering a medicament.The ratchet mechanism is shown in more detail in C, where flexible arms1002 are clearly seen to engage with sloped teeth 1502 of the plungerrod 1500.

Because the ratchet mechanism 1500, 1502, 1000, 1002 allows movement inone direction only, it is prevented that the plunger rod 1500 isreturned to the initial position. Thereby, it is avoided that a usedauto injector is re-fitted with another syringe and offered to a newuser. Thus, the ratchet mechanism 1500, 1502, 1000, 1002 further acts asan anti-tampering component.

FIG. 13 shows two different reload handles in more detail. It is seenthat the reload handle may be configured to allow for delivering of one,two, three, four or multiple doses. In FIG. 13a , a reload handle 1400having a reload handle slot 1412 having two straight sides is provided,so that the reload handle slot allows for longitudinal movement along anaxis of the auto injector only, and thereby does not allow for therotational movement along an inclined surface. This means that only oneinjection is possible and that no reload function is available. It isseen that the auto injector is in the initial position with torsion ringtab 1702 at the top of the reload handle slot 1404. In FIG. 13b , areload handle 1400 is shown having a reload handle slot 1414 having astraight side for the injection process and an inclined side 1416 whichthe torsion ring tab 1702 follows upon reloading. It is seen that thereload handle is provided with only two symmetric reload handle slots1414, and that therefore an infinite number of reloads is possible asthe rotation of the handle is never locked. This reload handle may forexample be advantageous if the auto injector is re-usable and allows forre-fitting with for example a new syringe assembly. Any combination ofthe two reload handles as shown in FIG. 13a and FIG. 13b may provide anycombination of a predetermined number of reloads following the slotdesign 1414 in FIG. 13b , followed by a locking slot 1412 not allowingfor further reloads. The number of reload slots is primarily limited bythe size of the auto injector.

In FIG. 14, a syringe assembly 20 is shown comprising syringe tube 800,syringe 900, plunger rod tube 1100, plunger rod 1500 and plunger roddriver 1600. It is envisaged that the parts may be assembled usingvarious connector parts, and furthermore, the plunger rod tube andsyringe tube may be provided as one part. It is seen that the syringeassembly 20 may be moved as one element and either be pushed forward bya syringe driver (1200 not shown in FIG. 14) acting on syringe tubeflange 806 and/or plunger rod flange 1114 or retracted by a reloadhandle action acting on the syringe assembly 20, such as on the syringeassembly tab 1112.

In FIG. 15, another auto injector according to an embodiment of thepresent invention is shown, comprising a cap or casing 1, a housing 2, askin sensor 3, a syringe tube or holder 4, and syringe 5 having a rigidneedle shield covering the needle in the stored position (not shown), aplunger rod 6 for acting on medicament in the syringe 5, a plunger roddriver, or motor spring, 7, a plunger rod tube 8 encompassing at least apart of the plunger rod driver 7 and of the plunger rod 6, and a syringedriver, such as motor spring, 9 configured to act on at least thesyringe 5, and preferably on a syringe assembly comprising syringe tube4, syringe 5, plunger rod 6, plunger rod driver 7 and plunger rod tube8. A needle shield driver, such as a needle shield spring, 13, isconfigured to act on the needle shield/skin sensor 3. The auto injectorfurther comprises a reload handle 11 and a reload handle top 12.

The auto injector 10 as unpacked is ready for use. The auto injector 10is applied to the injection site, which pushes the needle shield 3backwards a few millimeters.

Hereby, the plunger rod tube acts to release the syringe driver 9driving the plunger rod 6, and the plunger rod carrier or tube 8, andthereby syringe 5 forward resulting in the needle being inserted intothe patient. When the needle is inserted, the plunger rod spring 7 isreleased resulting in a first dose being administered. The plunger rod 6travels downwards until it hits a stop, which determines the dose size.Also, just before the plunger rod 6 comes to rest, the operator orpatient is given an audible feed in to signal “end of dose”. Progressionof the injection can also be observed through a window. After completionof an injection, the auto injector is lifted from the injection site andthe needle shield 3 is extended forward by the use of the needle shieldspring 10 and locks in its outer position where the combination ofopening diameter and distance from the needle tip ensures sharpsprotection. The auto injector is now disabled and can either bere-mounted with the cap and disposed of or the auto injector can beprepared for an second injection if needed. Thus, the auto injector isready for being prepared for the second injection. By turning the handletop 12, and thereby the reload handle 11, the plunger rod carrier ortube 8 and syringe carrier or tube 4 are retracted backwards. This isdone by a detail on the plunger rod carrier 8 engaging in a threadinside the reload handle 11. When the handle has been pulled back, theplunger rod carrier 8 and the syringe carrier 4 disables itself.Further, when the reload handle is turned, it unlocks the needle shield3 from its outer position, which enables the plunger rod carrier 8 andsyringe carrier 4 to be moved forward when actuated.

When the auto injector is applied to the injection site, the needleshield 3 is pushed backwards a few mm, and thereby, the syringe carrier4 is configured to release the insertion spring, or syringe motor, 9,thus driving the plunger rod 6 and the syringe carrier 4 forwardresulting in the needle being inserted into the patient. When the needleis inserted, the injection spring, i.e. plunger rod driver, 7 isreleased resulting in the first (or second or any further) dose beingadministered. The plunger rod 6 travels downwards until it hits a stop,which determines the dose size. Also, just before the plunger rod 6comes to rest, the patient or user is given an audible feed in to signal“end of dose”. Progression of the injection can also be observed througha window. After a second or any further injection, the needle shield 3is pushed forward by needle shield spring 13 as the needle is pulledback from the patient and the needle shield 3 locks in its outerposition. In addition to this, the reload handle 11 is also disabled,meaning that the entire device is disabled and can safely be disposedoff.

-   1 cap or casing-   2 lower housing-   3 needle shield-   4 syringe holder-   5 syringe with needle-   6 plunger rod-   7 plunger rod motor or driver-   8 plunger rod carrier-   9 syringe motor or driver-   10 reloadable auto-injector-   11 upper housing or reload handle-   12 reload handle top-   13 needle shield spring-   20 syringe assembly-   30 top portion of auto injector-   22, 24, 42, 44 arrows-   100 casing-   200 RNS (rigid needle shield) remover-   202 slit-   204 U-shaped cut out-   206 RNS (rigid needle shield) removal part tip-   208 fixation part-   300 RNS (rigid needle shield)-   400 housing-   402 inspection window-   404 label window-   500 syringe lock-   502 syringe lock inspection window-   504 syringe lock guide slot/trail-   506 syringe lock ledge-   508 a released position-   510 syringe lock end stop.-   512 syringe lock angled surface-   600 skin sensor-   602 skin sensor opening-   604 protrusion-   606 skin sensor angled surface-   700 skin sensor driver-   800 syringe tube-   802 syringe tube inspection window-   804 forward end-   806 syringe tube protrusions-   808 syringe tube flange-   810 syringe tube connectors-   900 syringe-   902 needle-   904 syringe content (medicament)-   908 syringe stopper-   910 lips-   1000 sound generator-   1002 flexible arms-   1100 plunger rod tube-   1101 forward end-   1102 first stop of the plunger rod tube—locking member stop-   1104 second stop of the plunger rod tube-   1106 end stop position-   1108 first locking member-   1109 first locking member angled surface-   1110 second locking member plunger rod tube tabs-   1112 plunger rod tube tab/syringe assembly tab-   1114 plunger rod tube flange-   1116 plunger rod tube connectors-   1118 back end of plunger rod tube-   1200 syringe driver-   1300 housing lock ring-   1400 reload handle-   1401 reload handle arrow-   1402 tapered knob-   1404 first reload handle slot-   1406 slot side-   1408 inclined slot side-   1410 top edge of the first reload handle slot-   1412 reload handle slot-   1414 second reload handle slot-   1420 first window-   1422 second window-   1424 inner surface-   1500 plunger rod-   1502 teeth-   1504 second stop-   1506 first stop-   1508 protrusion of the plunger rod, plunger rod stop-   1509 angled surface of plunger rod stop-   1510 forward end of the plunger rod-   1512 backward end of plunger rod-   1600 plunger rod driver-   1602 one end of plunger rod driver-   1700 torsion ring-   1702 torsion ring tab-   1800 handle top-   1900 skin barrier

The invention claimed is:
 1. An auto injector having sequential controlof needle insertion and dose injection, the auto injector comprising: ahousing, a syringe with a needle, the syringe being movably positionedin the housing between a first position in which the needle isaccommodated inside the housing and a second position in which theneedle is positioned to protrude outside the housing, a plunger rodconfigured to be advanced in the syringe for delivering a firstpredefined dose of medicament, a plunger rod tube having at least onelocking member configured to interact with a plunger rod stop tonormally lock the plunger rod to the plunger rod tube, a syringe driverconfigured to apply a force to the syringe thereby moving the syringefrom the first position to the second position, the syringe driver beingfurther configured to advance the plunger rod tube with the plunger rodto the second position, a plunger rod driver being configured to apply adriving force to the plunger rod to advance the plunger rod in thesyringe for delivering the first predefined dose of medicament, whereinthe housing is configured to unlock the at least one locking member andrelease the plunger rod from the plunger rod tube when the syringe andthe plunger rod tube are advanced to the second position, therebyactivating the plunger rod driver to advance the plunger rod in thesyringe for delivering the first predefined dose of medicament, whereinthe at least one locking member comprises at least one deflectablemember and wherein the housing is configured to allow for the at leastone deflectable member to enable deflection away from the plunger rodwhen the syringe and the plunger rod tube are advanced to the secondposition, and wherein the auto injector is reloadable and configured toretract the syringe within the housing to deliver a plurality ofseparate predefined doses of medicament including the first predefineddose of medicament from the syringe and a second predefined dose ofmedicament from the syringe, and wherein the plunger rod driver isconfigured to move the plunger a first distance to a first stop positionupon a first activation of the plunger rod driver for delivering thefirst predefined dose of medicament of the plurality of separatepredefined doses of medicament and a second distance from the first stopposition to a second stop position upon a second activation of theplunger rod driver for delivering the second predefined dose ofmedicament of the plurality of separate predefined doses of medicament.2. An auto injector according to claim 1, wherein the plunger rod tubeand the syringe are interconnected so that the plunger rod tube cannotmove in a longitudinal direction with respect to the syringe and viceversa, wherein the housing has an opening configured to be aligned withthe at least one deflectable member when the plunger rod tube isadvanced to the second position.
 3. An auto injector according to claim2, wherein the at least one deflectable member is configured to deflectupon being aligned with the opening in the housing.
 4. An auto injectoraccording to claim 1, wherein the plunger rod driver comprises a plungerrod spring, wherein the plunger rod spring at one end is fixedlyconnected to the plunger rod tube.
 5. An auto injector according toclaim 1, wherein the plunger rod driver applies the driving forcedirectly onto the plunger rod.
 6. An auto injector according to claim 1,wherein the housing further accommodates a syringe tube for holding thesyringe, and wherein the syringe is locked between the syringe tube andthe plunger rod tube.
 7. An auto injector according to claim 1, whereinthe plunger rod driver is provided inside the plunger rod tube, andwherein the syringe driver is provided outside the plunger rod tube. 8.An auto injector according to claim 1, wherein an inner surface of thehousing prevents the at least one deflectable member from deflecting,wherein, upon release of the plunger rod, the plunger rod driveradvances the plunger rod within the syringe such that the plunger rodstop is able to pass the at least one deflectable member.
 9. An autoinjector according claim 1, wherein the plunger rod stop has an angledsurface pressing against an angular surface of the at least onedeflectable member, wherein the at least one deflectable member ishinged to the plunger rod tube in a downward position with respect tothe movement of the plunger rod.
 10. An auto injector according claim 1,wherein the plunger rod tube comprises at least a first and a secondmember configured to sequentially engage with the plunger rod stop,wherein the housing comprises a first and a second opening configured toalign with the at least first and second locking members, respectively,when the syringe is in the second position.
 11. An auto injectoraccording to claim 1, wherein the second activation of the plunger roddriver follows a reload of the auto injector, and a repeated movement ofthe syringe with the needle from the first position to the secondposition.
 12. An auto injector according to claim 1, further comprisinga reload handle configured to reload the auto injector according to arotational movement during a user operation, wherein the reload handleis configured for the rotational movement, the auto injector furthercomprising an intermediate component transferring the rotationalmovement of the reload handle to a movement of at least the syringe withthe needle, wherein the intermediate component has a tab configured tomove along an inclined surface of the reload handle upon operation ofthe reload handle, wherein a first reload handle slot has an inclinedsurface to allow for continuous reloading of the auto injector, whereina complete operation of the reload handle forces the tab over aninclined surface top and into a second reload handle slot, wherein thesecond reload handle slot allows for longitudinal movement to therebyprevent further reload of the auto injector.
 13. An auto injectoraccording to claim 12, wherein the complete operation of the reloadhandle is configured to reverse an operation of the auto injector. 14.An auto injector according to claim 1, further comprising a syringe lockconfigured to lock the syringe in the first position, and a skin sensorconfigured to release the syringe lock upon engagement with skin of auser wherein the skin sensor is activated by pressing the skin sensoronto the skin of the user, wherein the activation of the skin sensor isconfigured to cause an upward movement of the skin sensor whereby a skinsensor angled surface is configured to engage with a syringe lock angledsurface translating lateral motion of the skin sensor into angularmotion of the syringe lock.
 15. An auto injector according to claim 14,wherein the syringe with the needle rests on a ledge in the syringe lockto lock the syringe in the first position and wherein the angular motionof the syringe lock releases the syringe with the needle.
 16. An autoinjector according to claim 1, wherein the plunger rod tube comprises aplunger rod tab, the plunger rod tab being configured to move in asyringe lock guide slot of a syringe lock from a released positionadjacent a syringe lock ledge to a syringe lock end stop, wherein thesyringe is moved from the first position to the second position when theplunger rod tab travels in the syringe lock guide slot from the releasedposition to the syringe lock end stop.
 17. An auto injector according toclaim 1, wherein forward motion of the syringe in the second position isrestricted by a plunger rod tab engaging a syringe lock end stop,wherein a skin sensor driver upon removal of the auto injector from auser's skin is configured to push a skin sensor forward to shield theneedle after each injection cycle.
 18. An auto injector according toclaim 1, wherein the syringe with the needle comprises a syringe tubeco-axially encompassing the syringe and the plunger rod tube co-axiallyencompassing the plunger rod, the syringe tube and the plunger rod tubebeing interconnected via syringe tube connectors engageable with plungerrod tube connectors, wherein the syringe with the needle is configuredto rest on a syringe lock ledge when an intermediate component tab isprovided in a first or second reload handle slot, wherein the reloadoperation is configured to reverse the syringe driver, a syringe lock,and a skin sensor.
 19. An auto injector according to claim 1, whereinthe housing further comprises an indicator for indicating a “ready”state and a “not ready” state, wherein the “ready” state indicates afirst rotational position of a syringe lock in which the syringe withthe needle is locked in the first position.
 20. An auto injectoraccording to claim 1, wherein the auto injector further comprises a skinsensor extending over a length of the needle when the syringe with theneedle is in the first position to hide the needle from a user's view,wherein the skin sensor is configured to extend over the length of theneedle as the needle is withdrawn after a dose has been delivered,wherein the skin sensor has a locked forward position and an unlockedforward position, wherein the skin sensor is unlocked from the lockedforward position to the unlocked forward position upon operation of areload handle.
 21. An auto injector according to claim 1, wherein theauto injector further comprises a sound generator configured to emit asound while dosing, wherein the sound generator comprises a ratchetmechanism, wherein the ratchet mechanism comprises flexible armspositioned with the syringe with the needle for engaging sloped teeth onthe plunger rod, wherein the ratchet mechanism allows for forwardmovement of the plunger rod.
 22. An auto injector according to claim 1,wherein the syringe with the needle further comprises an anti-tampercomponent, wherein the anti-tamper component comprises a protectionmechanism to ensure that backward movement of the plunger rod isprevented.
 23. An auto injector according to claim 1, wherein the autoinjector is reloadable, such that the syringe with the needle isreplaceable.
 24. An auto injector having sequential control of needleinsertion and dose injection, the auto injector comprising: a housing, asyringe with a needle, the syringe being movably positioned in thehousing between a first position in which the needle is accommodatedinside the housing and a second position in which the needle ispositioned to protrude outside the housing, a plunger rod configured tobe advanced in the syringe for delivering a first predefined dose ofmedicament, a plunger rod tube having at least one locking memberconfigured to interact with a plunger rod stop to normally lock theplunger rod to the plunger rod tube, a first spring configured to applya force to the syringe thereby moving the syringe from the firstposition to the second position, the first spring being furtherconfigured to advance the plunger rod tube with the plunger rod to thesecond position, a second spring configured to apply a force to theplunger rod to advance the plunger rod in the syringe for delivering thefirst predefined dose of medicament, wherein the at least one lockingmember is configured to be unlocked upon advancing the plunger rod tubewith the plunger rod to the second position thereby unlocking theplunger rod from the plunger rod tube and allowing the second spring toadvance the plunger rod in the syringe, wherein the auto injector isreloadable and configured to retract the syringe within the housing todeliver a plurality of separate predefined doses of medicament includingthe first predefined dose of medicament from the syringe and a secondpredefined dose of medicament from the syringe, and wherein the secondspring is configured to move the plunger a first distance to a firststop position upon a first activation of the second spring fordelivering the first predefined dose of medicament of the plurality ofseparate predefined doses of medicament and a second distance from thefirst stop position to a second stop position upon a second activationof the second spring for delivering the second predefined dose ofmedicament of the plurality of separate predefined doses of medicament.25. A method of delivering a plurality of doses of medicament using anauto injector, wherein the auto injector has a housing, a syringeassembly, the syringe assembly comprising a syringe with a needle, aplunger rod configured to be advanced in the syringe for delivering afirst predefined dose of medicament, a plunger rod tube having at leastone locking member configured to interact with a plunger rod stop tolock the plunger rod to the plunger rod tube, the method comprising thesteps of activating a syringe driver to apply a force to the syringethereby moving the syringe from a first position in which the needle isaccommodated inside the housing to a second position in which the needleis positioned to protrude outside the housing, and further advancing theplunger rod tube with the plunger rod to the second position, in thesecond position, unlocking the at least one locking member andactivating a plunger rod driver to apply a force to the plunger rod tothereby advance the plunger rod in the syringe for delivering the firstpredefined dose of medicament, wherein the syringe driver is a firstspring and the plunger rod driver is a second spring, delivering aplurality of separate predefined doses of medicament including the firstpredefined dose of medicament and a second predefined dose of medicamentfrom the syringe by retracting the syringe within the housing forreloading the auto injector to deliver the second predefined dose and bymoving the plunger, with the plunger rod driver, a first distance to afirst stop position upon a first activation of the plunger rod driverfor delivering the first predefined dose of medicament of the pluralityof separate predefined doses of medicament and a second distance fromthe first stop position to a second stop position upon a secondactivation of the plunger rod driver for delivering the secondpredefined dose of medicament of the plurality of separate predefineddoses of medicament from the syringe.